Periodic reporting (ASRs)
Additionally to the need for SUSARs, Annual Safety Reports (ASRs) should be submitted to regulatory authorities and Ethics Committees throughout the clinical trial or on request. The ASR takes into account all new available safety information received during the reporting period.
ASRs must be submitted at yearly intervals from the date of the CTA approval. For trials with marketed products, the date is the first marketing authorisation granted in the EU.
An ASR should briefly address any new safety information within a single clinical trial or a clinical trial programme assessing the safety of the subjects in the trial(s)
The report includes:
An analysis of patient cases and any affect on the benefit-risk of the trial and product.
A line listing of all Serious Adverse Drug Reaction from all active countries.
A cumulative summary of all SUSARs within the trial.
Consolidated safety reporting systems at PrimeVigilance, together with extensive in-house medical expertise provide the means for accurate and through ASR production.
PrimeVigilance - Accurate and Thorough
For more information contact PrimeVigilance today